| 2005 |
Dr. Boris Mey |
Marketing authorisation of medicinal products used to prevent the toxicity of chemical, biological, radiological or nuclear substances (MA of Anti-CBRN Drugs) |
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|
| 2005 |
Dr. Wolfgang Meyer |
Preclinical and clinical development of anticancer drugs - regulatory peculiarities |
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|
| 2005 |
Dr. Eva-Maria Möllenhoff |
Requirements for active pharmaceutical ingredients in marketing authorization applications |
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|
| 2005 |
Katharina Neumann |
New Pharmaceutical Legislation (Review 2004) - The Impact on the Generic Industry |
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|
| 2005 |
Dr. Rainer Paffenholz |
Nonclinical assessment of immunotoxicity in the EU, United States, and Japan |
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|
| 2005 |
Dr. Karen Rosenkranz |
Regulatory strategies for life-cycle management of chemical defined cytostatic drugs with regard to the new pharmaceutical legislation |
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|
| 2005 |
Dr. Sabine Schiemann |
New aspects in comparability studies of biotechnological products subject to changes in the manufacturing process |
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|
| 2005 |
Ingrid Schulz |
Comparison of CMC requirements for Clinical Trials in the US and the European Union |
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|
| 2005 |
Dr. Daniel Schwarz |
Regulatory requirements in Europe for the development of active pharmaceutical ingredients derived from transgenic plants |
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|
| 2005 |
Dr. Thomas Stoiber |
Introduction of electronic systems supporting the submission management of the Regulatory Affairs department in a medium-sized pharmaceutical company, with special focus on the implementation of the ICH eCTD standard |
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|
| 2005 |
Dr. Karin Streso |
Demarcation of medicinal products and food in the European Union - Focus on food supplements |
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|
| 2005 |
Dr. Michael Sych |
Structure and implementation of an adequate quality assurance system in a pharmaceutical start-up company |
|
|
| 2005 |
Ute Ukelis |
Replacement of In Vivo ATC Studies by In Vitro Cytotoxicity Methods |
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|
| 2005 |
Elke Wehres-Losch |
Die Anmeldung klinischer Prüfungen in Deutschland nach der 12. AMG-Novelle Erste Erfahrungen und kritische Aspekte aus Sicht der pharmazeutischen Industrie |
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|
| 2005 |
Dr. Bernhard Wenkers |
Balancing Regulatory and Economic Aspects in the Development of Generics a Business Case |
|
|
| 2005 |
Dr. Oliver Weyand |
Generic Medicinal Product Portfolio from a Regulatory and Business Development point of view |
|
|
| 2005 |
Dr. Arno Wiehe |
Data protection for the development of known drug substances - Changes with the review of EU legislation |
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|
| 2005 |
Matthias Wilken |
Empfehlungen zur Erstellung eines Maßnahmeplans unter Anpassung an die aktuellen gesetzlichen Vorgaben unter spezieller Berücksichtigung der 12. AMG-Novelle |
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|
| 2005 |
Dr. Doris Wolf |
Safety reporting in clinical trials |
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|
| 2005 |
Hiu Wah Yuen |
Implementing CMC Section of the Clinical Trial Directive |
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